Trial Information

Immunotherapy for Breast Carcinoma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy

OBJECTIVES:

- Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine
and sargramostim (GM-CSF) followed by monoclonal antibody OKT3- activated T lymphocytes
and interleukin-2 in combination with standard therapy in terms of response rate in
patients with stage III or IV breast cancer.

- Determine the immunogenicity of breast cancer in this patient population.

OUTLINE: Patients are stratified according to extent of disease at the time of
immunotherapy, extent of antigen specific response to vaccination, performance status (0 vs
1), prior therapy (yes vs no), and gender.

Patients undergo surgical debulking of tumor on week 1 followed by adjuvant chemotherapy.
Within 2-4 weeks of chemotherapy, patients are vaccinated with irradiated autologous tumor
cells and sargramostim (GM-CSF), then receive GM-CSF alone intradermally at vaccination
sites daily for 4 days. Patients are revaccinated 2 weeks later.

Patients undergo peripheral blood mononuclear cell collection two weeks after the second
vaccination. Peripheral blood mononuclear cells are stimulated with anti-CD3 monoclonal
antibody (OKT3) and interleukin-2, producing activated T lymphocytes. The activated T
lymphocytes are infused IV over 1-6 hours followed by 5 doses of interleukin-2 IV every
other day over 10 days. Treatment continues in the absence of disease progression or
unacceptable toxicity.

Patients may receive one additional course of immunotherapy as above.

Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.